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https://www.readbyqxmd.com/read/29021228/immune-reconstitution-and-survival-of-100-scid-patients-post-hematopoietic-cell-transplant-a-pidtc-natural-history-study
#1
Jennifer Heimall, Brent R Logan, Morton J Cowan, Luigi D Notarangelo, Linda M Griffith, Jennifer M Puck, Donald B Kohn, Michael A Pulsipher, Suhag Parikh, Caridad Martinez, Neena Kapoor, Richard O'Reilly, Michael Boyer, Sung-Yun Pai, Frederick Goldman, Lauri Burroughs, Sharat Chandra, Morris Kletzel, Monica Thakar, James Connelly, Geoff Cuvelier, Blachy Davila, Evan Shereck, Alan Knutsen, Kathleen E Sullivan, Kenneth DeSantes, Alfred Gillio, Elie Haddad, Aleksandra Petrovic, Troy Quigg, Angela R Smith, Elizabeth Stenger, Ziyan Yin, William T Shearer, Thomas Fleisher, Rebecca H Buckley, Christopher C Dvorak
The Primary Immune Deficiency Treatment Consortium (PIDTC) is enrolling children with severe combined immunodeficiency (SCID) to a prospective natural history study. We analyzed patients treated with allogeneic hematopoietic cell transplantation (HCT) from 2010-2014, including 68 with typical SCID and 32 with leaky SCID, Omenn Syndrome or Reticular Dysgenesis. Most (59%) were diagnosed by newborn screening or family history. The 2-year overall survival (OS) was 90%but was 95% for those infection-free at HCT vs...
October 11, 2017: Blood
https://www.readbyqxmd.com/read/28990161/real-time-ultrasound-guided-axillary-vein-cannulation-in-children-a-randomised-controlled-trial
#2
E-H Kim, J-H Lee, I-K Song, H-S Kim, Y-E Jang, S-N Choi, J-T Kim
The axillary vein is a good site for ultrasound-guided central venous cannulation in terms of infection rate, patient comfort and its anatomical relationship with the clavicle and lungs. We compared real-time ultrasound-guided axillary vein cannulation with conventional infraclavicular landmark-guided subclavian vein cannulation in children. A total of 132 paediatric patients were randomly allocated to either ultrasound-guided axillary vein (axillary group) or landmark-guided subclavian vein (landmark group)...
October 9, 2017: Anaesthesia
https://www.readbyqxmd.com/read/28983464/radiotherapy-dosing-for-locally-advanced-non-small-cell-lung-carcinoma-mtd-or-alara
#3
REVIEW
Nitin Ohri
Locally advanced non-small cell lung cancer (LA-NSCLC) is typically treated with thoracic radiotherapy, often in combination with cytotoxic chemotherapy. Despite tremendous advances in the evaluation, treatment techniques, and supportive care measures provided to LA-NSCLC patients, local disease progression and distant metastases frequently develop following definitive therapy. A recent landmark randomized trial demonstrated that radiotherapy dose escalation may reduce survival rates, highlighting our poor understanding of the effects of thoracic radiotherapy for LA-NSCLC...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/28982956/the-laser-in-glaucoma-and-ocular-hypertension-light-trial-a-multicentre-randomised-controlled-trial-baseline-patient-characteristics
#4
Evgenia Konstantakopoulou, Gus Gazzard, Victoria Vickerstaff, Yuzhen Jiang, Neil Nathwani, Rachael Hunter, Gareth Ambler, Catey Bunce
PURPOSE: The laser in glaucoma and ocular hypertension (LiGHT) trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open angle glaucoma (POAG) or ocular hypertension (OHT). DESIGN: LiGHT is a prospective unmasked, multicentre, pragmatic, randomised controlled trial (RCT). PARTICIPANTS: 718 previously untreated patients with POAG or OHT were recruited at 6 UK centres between 2012 and 2014...
October 5, 2017: British Journal of Ophthalmology
https://www.readbyqxmd.com/read/28982487/management-of-muscle-invasive-urothelial-cancer-and-the-emerging-role-of-immunotherapy-in-advanced-urothelial-cancer
#5
REVIEW
Karthik V Giridhar, Manish Kohli
The incidence of bladder cancer has increased in the past decade, and mortality from bladder cancer remains a substantial public health burden. After 3 decades of minimal progress in the treatment of advanced-stage disease, recent advances in the genomic characterization of urothelial cancer and breakthroughs in bladder cancer therapeutics have rejuvenated the field. This review highlights the landmark clinical trials of chemotherapy in both the neoadjuvant and advanced or metastatic urothelial carcinoma settings...
October 2017: Mayo Clinic Proceedings
https://www.readbyqxmd.com/read/28982262/adaptive-designs-the-swiss-army-knife-among-clinical-trial-designs
#6
Frank Bretz, Paul Gallo, Willi Maurer
There has been considerable progress in the development and implementation of adaptive designs over the past 30 years. A major driver for this class of novel designs is the possibility to increase the information value of clinical trial data to enable better decisions, leading to more efficient drug development processes and improved late-stage success rates. In the first part of this article, we review the development of adaptive designs from different perspectives. We trace back key historical papers, report on landmark adaptive design clinical trials, review major cross-industry collaborations, and highlight key regulatory guidance documents...
October 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28979511/glycaemic-control-in-intensive-care-everything-in-moderation
#7
Arjun Devanesan, Jonathan Lloyd, Hanif Samad, Shibaji Saha
INTRODUCTION: Glycaemic control is an important predictor of mortality in sepsis. Various international organizations including the Surviving Sepsis campaign recommend glycaemic control in critical illness with a glucose target between 6.1-10 mmol/L. The NICE-SUGAR Trial in 2009 was a landmark in the debate over tight versus liberal glycaemic control in the critically ill and subsequent guidelines have been adjusted to reflect a move towards moderate glycaemic control. METHODS: We conducted a nation-wide study comparing glucose targets used in intensive care units in the United Kingdom in 2007 with those used in 2014 to 2015 to see the impact of the NICE-SUGAR study and subsequent guideline changes...
November 2016: J Intensive Care Soc
https://www.readbyqxmd.com/read/28966335/randomized-prospective-comparison-of-everolimus-eluting-vs-sirolimus-eluting-stents-in-patients-undergoing-percutaneous-coronary-intervention%C3%A3-3-year-clinical-outcomes-of-the-excellent-randomized-trial
#8
Kyung Woo Park, Tae-Min Rhee, Hyun-Jae Kang, Bon-Kwon Koo, Hyeon-Cheol Gwon, Jung-Han Yoon, Do-Sun Lim, In-Ho Chae, Kyoo-Rok Han, Taehoon Ahn, Myung-Ho Jeong, Dong-Woon Jeon, Yang-Soo Jang, Hyo-Soo Kim
BACKGROUND: Everolimus-eluting stents (EES) have equivalent short-term angiographic and clinical outcomes to sirolimus-eluting stents (SES), but EES may be superior to SES with regard to long-term clinical safety. We report the 3-year clinical outcomes of EES and SES from the prospective EXCELLENT Randomized Trial (NCT00698607).Methods and Results:We randomly assigned 1,443 patients undergoing percutaneous coronary intervention 3:1 to receive EES and SES, respectively. We investigated endpoints including target lesion failure (TLF) and individual clinical outcomes including stent thrombosis (ST) at 3 years...
September 30, 2017: Circulation Journal: Official Journal of the Japanese Circulation Society
https://www.readbyqxmd.com/read/28961845/borealis-1-a-randomized-first-line-placebo-controlled-phase-ii-study-evaluating-apatorsen-and-chemotherapy-for-patients-with-advanced-urothelial-cancer
#9
J Bellmunt, B J Eigl, E Senkus, Y Loriot, P Twardowski, D Castellano, N Blais, S S Sridhar, C N Sternberg, M Retz, S Pal, B Blumenstein, C Jacobs, P S Stewart, D P Petrylak
Background: Five-year survival of patients with inoperable, advanced urothelial carcinoma treated with the first-line chemotherapy is 5%-15%. We assessed whether the Hsp27 inhibitor apatorsen combined with gemcitabine plus cisplatin (GC) could improve overall survival (OS) in these patients. Patients and methods: This placebo-controlled, double-blind, phase II trial randomized 183 untreated urothelial carcinoma patients (North America and Europe) to receive GC plus either placebo (N = 62), 600 mg apatorsen (N = 60), or 1000 mg apatorsen (N = 61)...
October 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28961826/whole-brain-radiotherapy-after-stereotactic-radiosurgery-or-surgical-resection-among-patients-with-one-to-three-brain-metastases-and-favorable-prognoses-a-secondary-analysis-of-eortc-22952-26001
#10
T M Churilla, E Handorf, S Collette, L Collette, Y Dong, A A Aizer, M Kocher, R Soffietti, B M Alexander, S E Weiss
Background: The absence of a survival benefit for whole brain radiotherapy (WBRT) among randomized trials has been attributed to a competing risk of death from extracranial disease. We re-analyzed EORTC 22952 to assess the impact of WBRT on survival for patients with controlled extracranial disease or favorable prognoses. Patients and methods: We utilized Cox regression, landmark analysis, and the Kaplan-Meier method to evaluate the impact of WBRT on survival accounting for (i) extracranial progression as a time-dependent covariate in all patients and (ii) diagnosis-specific graded prognostic assessment (GPA) score in patients with primary non-small-cell lung cancer (NSCLC)...
October 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28960653/the-efficacy-and-safety-of-dorsal-root-ganglion-stimulation-as-a-treatment-for-neuropathic-pain-a-literature-review
#11
REVIEW
Conrad Harrison, Sarah Epton, Stana Bojanic, Alexander L Green, James J FitzGerald
OBJECTIVE: Dorsal root ganglion stimulation (DRGS) received its first regulatory approval (CE marking in Europe) in late 2011, and so its use is now almost six years old. Several thousand patients have already been treated, and a landmark trial in lower limb complex regional pain syndrome (CRPS) and causalgia has recently been published. METHODS: In this review we have summarized the literature to date on the use of DRGS in the treatment of neuropathic pain. RESULTS: The results so far are encouraging, with reports of successful use in treating a wide range of indications including postsurgical pain, CRPS, and phantom pain...
September 28, 2017: Neuromodulation: Journal of the International Neuromodulation Society
https://www.readbyqxmd.com/read/28950817/specific-patient-features-affect-antiepileptic-drug-therapy-decisions-focus-on-gender-age-and-psychiatric-comorbidities
#12
Pisani Laura Rosa, Nikanorova Marina, Johannessen Landmark Cecilie, Johannessen Svein Ivor, Pisani Francesco
BACKGROUND: Patient features, apart from the type of seizues/epilepsy, affect markedly antiepileptic drug (AED) choice and dosage. The present review focuses on gender, age and psychiatric comorbidities which play a leading role in influencing antiepileptic treatment. METHODS: Reviews with large population of patients, controlled clinical trials, observational investigations, experimental studies and experimental reviews of experimental data, where appropriated, were analysed and illustrated to produce the most homogeneous indications possible...
September 25, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28943161/ultrasound-guided-versus-landmark-guided-local-corticosteroid-injection-for-carpal-tunnel-syndrome-a-systematic-review-and-meta-analysis-of-randomized-controlled-clinical-trials
#13
REVIEW
Arash Babaei-Ghazani, Peyman Roomizadeh, Bijan Forogh, Seyed-Mohammad Moeini-Taba, Amin Abedini, Mona Kadkhodaie, Fateme Jahanjoo, Bina Eftekharsadat
OBJECTIVE: To review the literature and assess the comparative effectiveness of ultrasound-guided versus landmark-guided local corticosteroid injections in patients with carpal tunnel syndrome (CTS). DATA SOURCES: Cochrane Central Register of Controlled Trials, MEDLINE (PubMed), EMBASE (Ovid), and Web of Science (from inception to 1 February 2017). STUDY SELECTION: Randomized controlled trials (RCTs) comparing ultrasound-guided injection to landmark-guided injection in patients with CTS were included...
September 21, 2017: Archives of Physical Medicine and Rehabilitation
https://www.readbyqxmd.com/read/28943007/thoracic-endovascular-aortic-repair-migration-and-aortic-elongation-differentiated-using-dual-reference-point-analysis
#14
Hillary B Alberta, Toshio Takayama, Annalise Panthofer, Richard P Cambria, Mark A Farber, William D Jordan, Jon S Matsumura
OBJECTIVE: We evaluated images of patients undergoing a thoracic endovascular aortic repair procedure using two reference points as a means for differentiating stent graft migration from aortic elongation. Conventional standards define migration of a stent graft as an absolute change in the distance from the distal graft ring to a distal landmark ≥10 mm compared with a baseline measurement. Aortic elongation occurs over time in both healthy individuals and patients with aortic disease...
September 21, 2017: Journal of Vascular Surgery
https://www.readbyqxmd.com/read/28940605/adjuvant-chemotherapy-after-radical-nephroureterectomy-does-not-improve-survival-in-patients-with-upper-tract-urothelial-carcinoma-a-joint-study-by-the-european-association-of-urology-young-academic-urologists-and-the%C3%A2-upper-tract-urothelial-carcinoma-collaboration
#15
Andrea Necchi, Salvatore Lo Vullo, Luigi Mariani, Marco Moschini, Kees Hendricksen, Michael Rink, Roman Sosnowski, Jakub Dobruch, Jay D Raman, Christopher G Wood, Vitaly Margulis, Morgan Roupret, Alberto Briganti, Francesco Montorsi, Evanguelos Xylinas, Shahrokh F Shariat
OBJECTIVE: To analyse the outcomes of adjuvant chemotherapy vs observation in a multicentre cohort of patients with upper tract urothelial carcinoma (UTUC) in order to clarify whether such patients benefit from adjuvant chemotherapy after radical nephroureterectomy (RNU). PATIENTS AND METHODS: Data from 15 centres were collected for a total of 1544 patients, treated between 2000 and 2015. Criteria for patient selection included pT2-4N0/x stage, or lymph node-positive disease, and prior RNU...
September 20, 2017: BJU International
https://www.readbyqxmd.com/read/28936594/transcatheter-aortic-valve-replacement-outcomes-indications-complications-and-innovations
#16
REVIEW
Michael N Young, Ignacio Inglessis
Transcatheter aortic valve replacement (TAVR) has become the standard of care for the treatment of severe aortic stenosis in individuals who are at prohibitive surgical risk and presents a viable alternative to surgery in selected patients who are at high operative risk. To date, outcomes from the PARTNER (Placement of AoRtic TraNscathetER Valve) and Medtronic CoreValve® US Pivotal trials continue to show the benefits of TAVR in these high-risk subgroups out to 5 and 3 years, respectively (as reported by Mack et al...
September 22, 2017: Current Treatment Options in Cardiovascular Medicine
https://www.readbyqxmd.com/read/28934786/long-term-cost-utility-of-spinal-cord-stimulation-in-patients-with-failed-back-surgery-syndrome
#17
S Harrison Farber, Jing L Han, Aladine A Elsamadicy, Qasim Hussaini, Siyun Yang, Promila Pagadala, Beth Parente, Jichun Xie, Shivanand P Lad
BACKGROUND: Failed back surgery syndrome (FBSS) is a cause of significant morbidity for up to 40% of patients following spine surgery, and is estimated to cost almost $20 billion. Treatment options for these patients currently include conventional medical management (CMM), repeat operation, or spinal cord stimulation (SCS). Much of the published data regarding cost effectiveness of SCS comprise smaller scale randomized controlled trials (RCTs) rather than large databases capturing practices throughout the US...
September 2017: Pain Physician
https://www.readbyqxmd.com/read/28925859/effects-of-evolocumab-on-cardiovascular-events
#18
Nasser Mikhail
BACKGROUND: Evolocumab is a potent lipid-lowering drug that decreases plasma levels of low-density lipoprotein cholesterol (LDL-C) by 50-60%. FOURIER is a landmark randomized, trial involving 27,564 patients with established cardiovascular disease already on statins and plasma LDL-C levels > 70 mg/dl. OBJECTIVE: the main objective of FOURIER was to examine the effects of evolocumab on cardiovascular events. RESULTS: After a mean follow-up of 2...
September 18, 2017: Current Cardiology Reviews
https://www.readbyqxmd.com/read/28923101/durable-response-rate-as-an-endpoint-in-cancer-immunotherapy-insights-from-oncolytic-virus-clinical-trials
#19
Howard L Kaufman, Robert H I Andtbacka, Frances A Collichio, Michael Wolf, Zhongyun Zhao, Mark Shilkrut, Igor Puzanov, Merrick Ross
BACKGROUND: Traditional response criteria may be insufficient to characterize full clinical benefits of anticancer immunotherapies. Consequently, endpoints such as durable response rate (DRR; a continuous response [complete or partial objective response] beginning within 12 months of treatment and lasting ≥6 months) have been employed. There has not, however, been validation that DRR correlates with other more traditional endpoints of clinical benefit such as overall survival. METHODS: We evaluated whether DRR was associated with clinically meaningful measures of benefit (eg, overall survival [OS], quality of life [QoL], or treatment-free interval [TFI]) in a phase 3 clinical trial of an oncolytic virus for melanoma treatment...
September 19, 2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/28922326/the-smile-index-part-1-a-large-scale-study-of-phenotypic-norms-for-pre-and-post-operative-unilateral-cleft-lip
#20
Caroline A Yao, Thomas Imahiyerobo, Jordan Swanson, Allyn Auslander, Diego De Cardenas, Jane C Figueiredo, Meghan McCullough, Melinda Costa, Richard Vanderburg, William P Magee
BACKGROUND: Unilateral cleft lip has a spectrum of disease morphology but severity assessments are difficult given the absence of an accessible, objective assessment tools or reference data. We characterize the spectrum of cleft morphology before and after surgical repair for a large, multi-ethnic population using easily identifiable facial landmarks collected through a novel smart phone-based application. METHODS: Anthropometric measurements and standardized photographs were prospectively collected in Morocco, Bolivia, Vietnam and Madagascar during medical missions in 2015 utilizing an application designed specifically for the study...
September 14, 2017: Plastic and Reconstructive Surgery
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